In Campbell-Ewald Co. v. Gomez, 136 S. Ct. 663 (2016), the United States Supreme Court held that a defendant’s unaccepted offer of complete relief under Federal Rule of Civil Procedure 68 did not moot a class plaintiff’s...more

On June 12, 2017, the United States Supreme Court, in an opinion authored by Justice Ginsburg, held that “[f]ederal courts of appeals lack jurisdiction under [28 U.S.C.] § 1291 to review an order denying class certification...more

In a significant victory for class action defendants, whose success often depends on whether a class is certified, the US Supreme Court has ruled that federal courts of appeals lack jurisdiction under 28 USC §1291 to review...more

Imagine preparing for that big meeting on your way to work, while you ride along in your car—without the need for a driver. What sounds like it might be out of a sci-fi movie, may actually be the not-so-distant future. Such...more

The Waymo v. Uber trade secrets litigation has been underway for less than two months but the case has already hit quite few speed bumps with multiple discovery battles, Waymo’s efforts to obtain a preliminary injunction from...more

The judge presiding over the pending biosimilar litigation between Janssen and Celltrion/Hospira has issued guidance regarding the ramifications of a potential standing defect. Judge Wolf opined that Janssen’s biosimilar...more

After oral arguments on February 9th, the Ninth Circuit denied the government’s request to reinstate the travel ban EO. State of Washington v. Trump.
More than 135,000 people listened to the Ninth Circuit oral argument,...more

Today, the U.S. Supreme Court decided one of the Term’s most closely watched cases: Spokeo, Inc. v. Robins. The 6-2 decision, while far from sweeping, creates a hurdle for plaintiffs in “no-injury” class actions....more

Judge Jeffrey Alker Meyer of the District of Connecticut recently released an opinion that is significant to litigants on either side of a covenant not to sue. In a complex case with a host of claims and counterclaims...more

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more

Under O2 Micro, a District Court Must Provide a Claim Construction if the Parties Dispute the Meaning of a Claim Term -
In Eon Corp. IP Holdings LLC v. Silver Springs Networks, Inc., Appeal No. 2015-1237, the Federal...more

The Supreme Court of the United States issued one per curiam decision on March 21, 2016:
Caetano v. Massachusetts, No. 14-10078: Massachusetts enacted a law prohibiting the possession of stun guns. That law was upheld...more

Last week, a federal court in Atlanta issued an order preliminarily approving a proposed settlement – valued up to $19.5 million – of the consumer claims arising from the 2014 theft of payment card data from Home Depot. The...more

In the last month, the Food and Drug Administration has suffered setbacks relating to off-label promotion oversight. In both cases, one involving a pharmaceutical company and the other a medical device firm and its Chief...more

The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion.
On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to...more

Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading”...more

We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against Amarin over truthful,...more

In a case of first impression, the U.S. Court of Appeals for the Federal Circuit upheld the constitutionality of inter partes review (IPR) proceedings. The Federal Circuit ruled that because patents were a public right,...more

A cross-disciplinary team of Ropes & Gray attorneys advised Pacira Pharmaceuticals on its December 14 settlement agreement with FDA. On behalf of Pacira, Ropes & Gray had filed suit against FDA in September 2015 in the U.S...more

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

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